Home NDC 47335-343-16 Cetirizine Hydrochloride
Product NDC 47335-343
Requested package NDC 47335-343-16
11-digit product format 473350343
Labeler code 47335
Product ID 47335-343_358269d0-02b4-4efe-8acb-1a3e77a47e7e
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090142
Marketing category ANDA
Marketing start 2011-09-09
Marketing end 0000-00-00
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2011-08-30 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2011-08-30 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2011-08-30 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2011-08-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-003 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090142-004 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 10MG TABLET, CHEWABLE / ORAL 2011-08-30 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47335-343-83 Cetirizine Hydrochloride 30 in 1 BOTTLE TABLET, CHEWABLE 30 12 47335-343-88 Cetirizine Hydrochloride 100 in 1 BOTTLE TABLET, CHEWABLE 100 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 GUAR GUM INACTIVE INGREDIENT E89I1637KE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 MAGNESIUM OXIDE INACTIVE INGREDIENT 3A3U0GI71G CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 5 CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 CETIRIZINE ACTIVE MOIETY YO7261ME24 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 GUAR GUM INACTIVE INGREDIENT E89I1637KE CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 MAGNESIUM OXIDE INACTIVE INGREDIENT 3A3U0GI71G CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-343 CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 11 Legacy NDC, 2 package rows 20240920_a4758152-97dd-4a27-b4d9-11178654b93e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 47335-343-16 47335034316 100 TABLET, CHEWABLE in 1 BOTTLE (47335-343-16) 2011-09-26 0000-00-00 No No Current